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Learn all you need to know about current methods for assessing the risk posed by genotoxic impurities

The control of genotoxic impurities is crucial for ensuring regulatory compliance. With the implementation of increasingly stringent regulations for impurity levels, it is more important than ever for drug manufacturers to employ effective strategies for identifying, analysing and controlling GIs in their products.

Using a combination of theory and practical case studies, the course will allow delegates to develop the knowledge needed to overcome everyday problems and enhance performance, ensuring you are employing the most appropriate analytical strategies for your products.

Examining in detail the ICH guideline, its implications and its impact on control strategies

Learning about current methods for assessing the risk posed by genotoxic impurities

Exploring crucial strategies for safety testing

Reviewing strategies for genotoxic impurity analysis

Practical advice for overcoming everyday problems through the use of case studies and practical exercises

Andrew Teasdale, PhD, has over 20 years of experience in analytical chemistry and quality assurance. He has published numerous papers relating to GIs and has been a regular speaker on genotoxic impurities at conferences. He has led two expert groups in the field of genotoxic impurities, including an analytical group in the UK and a Project Quality Research Institute (PQRI) working group.

David Elder studied chemistry at Newcastle-upon-Tyne (BSc, MSc), before moving to Edinburgh to study for a PhD in Crystallography. He is a visiting professor at King’s College, London. After 39 years of experience at a variety of companies, he recently retired from his role as Director within the product development group in GSK R&D. He is currently an independent CMC consultant.

This course is relevant to anyone involved in identifying / analysing / controlling / reporting of GTIs including those working in:

Analytical Chemistry/Validation/R&D

CMC

Development Chemistry

Genetic Toxicology

Impurities

Laboratory Management

Pharmaceutical Development

Regulatory Affairs

Safety Assessment

Toxicology

Specifications for Small Molecule Drug Products Webinar

Led by Dr Mark Powell, a Fellow of the Royal Society of Chemistry (RSC) with over 25 years’ experience as a senior analytical chemist. In 2013, Mark set up Mark Powell Scientific, a company that offers training and consultancy services in analytical chemistry.